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Clinical Trials/NCT06593847
NCT06593847
Completed
Not Applicable

Multisite Virtual Reality Intervention for Speech Anxiety

Boston University Charles River Campus13 sites in 5 countries1,542 target enrollmentOctober 8, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Public Speaking
Sponsor
Boston University Charles River Campus
Enrollment
1542
Locations
13
Primary Endpoint
Public Speaking Anxiety
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present multicenter study (conducted through the Exposure Therapy Consortium) is designed to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. Further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism.

Detailed Description

The goal of this multicenter clinical trial is to examine predictors of VR exposure therapy outcomes for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. Further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism. State affect is manipulated at an experimental level with affect induction procedures; trait positive affectivity is measured at baseline. The study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing VR-based exposure therapy. Public speaking and social anxiety outcomes are measured immediately post-intervention and one week later. The one-week follow-up assessment represents the primary outcome.

Registry
clinicaltrials.gov
Start Date
October 8, 2024
End Date
July 23, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Self-report of 18 - 70 years of age
  • Current student at a participating University
  • Ability to read English to provide informed consent
  • Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).
  • For Phase 2: speech anxiety scale score of ≥ 18 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)

Exclusion Criteria

  • Previous participation (i.e., no participant may take the survey more than once).

Outcomes

Primary Outcomes

Public Speaking Anxiety

Time Frame: One week follow-up assessment

Assessed using the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS). Scores range from 6 to 30, with higher scores associated with higher public speaking anxiety.

Secondary Outcomes

  • Valence(One week follow-up assessment)
  • Assessed using the Social Phobia Inventory (SPIN)(One week follow-up assessment)
  • Public Speaking Anxiety(Post-treatment assessment immediately after the intervention)

Study Sites (13)

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